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Gireesh Babu, New Delhi December 07 , 2023
The National Commission for Homoeopathy (NCH) has notified the regulations to set standards for medical research in Homoeopathy in the country, including setting up of a research regulation committee to set standards and monitor research progress. The regulation also has provisions to research misconduct, non compliance or violation of mandatory guidelines, among others.

The notification is in line with the National Commission of Indian System of Medicine’s (NCISM) notification of regulation to set standards for medical research in the Indian System of Medicine (ISM).

While conducting the research, all stakeholders are expected to follow the certain guidelines for ethical and scientific reasons, including that all clinical trials relating to Homoeopathy must be conducted in accordance with the good clinical practices of Homoeopathy.

Additionally, they should not be in contravention to any of the international or national regulatory guidelines for bio medical research including but not limited to Drugs and Cosmetic Act 1940, and Rules (1945) and applicable amendments thereafter; declaration of Helsinki (2013 or later versions, as applicable); Good Clinical Practice guidelines of the Union ministry of health and family welfare (2001 or later versions, as applicable); National Guidelines for Biomedical and Health Research involving Human Participants (2017 or later versions as applicable); National Ethical Guidelines for Biomedical Research Involving Children (2017 or later versions as applicable); Indian Council of Medical Research Policy on Research Integrity and Publication Ethics (2019 or later versions as applicable), and other relevant regulations and guidelines, wherever applicable.

For animal experiments, rules and guidelines as notified by the Committee for the Control and Supervision of Experiments on Animal (CCSEA), under the Government of India are to be followed.

The sponsor of an applicable trial will be considered the responsible party, unless a qualified principal investigator or coordinator initiates a research or trial (investigator-initiated research or trial) where she or he will be responsible and designated so by a grant, contractor, or award as the responsible party.

All interventional clinical trials/studies shall be registered by the responsible party with Clinical Trial Registry of India (CTRI) before the enrolment of the first participant in the specific clinical trial. The NCH can authorise a team of experts or third-party agency for the audit of the research or trial at any time during or after the trial for which the responsible party shall cooperate fully and provide logistic support as may be required by the auditors.

The regulation enables the Commission to take actions including sanctions and disciplinary actions in proven research misconduct, noncompliance or violation of mandatory guidelines in proportion to the findings.

This includes warning or reprimand letter, penalties including withdrawal of grant, withdrawal of publications etc. The Commission shall also come out with guidelines for future monitoring and take legal action, as per expert advice.

The regulation defines misconduct of research as actions including fabrication, falsification, plagiarism, self-plagiarism, or deception in proposing, carrying out or reporting results of research; deliberate, dangerous or negligent deviations from accepted practices in carrying out research; failure to follow established protocols if this failure results in unreasonable risk or harm to humans or the environment and facilitate misconduct in research by collusion in, or concealment of, such actions by others; and intentional, unauthorized use, disclosure or removal of, or damage to, research-related property of another, including apparatus, materials, writings, data, hardware or software or any other substance(s) or device(s) used in or produced by the conduct of research.

The organisations conducting research are responsible to investigate all allegations of research misconduct made against its research team in an unprejudiced manner. The organisation should define responsibilities of each research participant in research at every level.

Each organisation must have formal written procedures in place for dealing with allegations of research misconduct against its staff and students and other researchers. Anyone accused of misconduct should have the right to respond and to appeal.

Appropriate sanctions and disciplinary procedures should be in place for cases when the allegation is upheld and if appropriate, efforts should be made to restore the reputation of the organization and/or accused party if the allegation is dismissed, it added.

The Homoeopathic Research Regulation Committee under the Chairmanship of Advisor (Homoeopathy), Ministry of Ayush, with members including Director General Central Council for Research in Homoeopathy, two experts from Homoeopathy with a minimum of 20 years of research experience in the field, an academic expert, one expert each from bioethicist and bio-statistics with prescribed experience, two experts from basic sciences or pharmacy or biotechnology or modern medicine or public health, and one pharmacologist. The President of the Homoeopathy Education Board will be the convenor.

The Committee shall have a term of three years from the date of constitution and should meet at least twice a year. It shall work on the agenda by the Homoeopathy education board.

It shall also draw guidelines on specific issues as referred to from time to time for Homoeopathic research, ensuring high quality performance in terms of quantity, consistency, collaboration, quality and other aspects of excellence and ensuring highest standards of ethics and participant protection in the research domain.

The Committee shall have the power to monitor a study progress for a definite time period as per need of the case referred to it for consideration. It shall also give its recommendations on the research projects, referred to it by the authorities, relating to violation of the mandatory guidelines issued by the Government of India from time to time, and it should also deal with appeals of aggrieved party relating to research misconduct as referred by the Commission and shall submit report with recommendations to the Commission.

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